JP6545723B2 - Intravascular thromboembolism removal device having multiple clot engaging elements - Google Patents

Description

  The present disclosure relates generally to devices used in body cavities such as blood vessels and methods of using the same.

  Various medical conditions may be caused, at least in part, by blockages or occlusions or clots of blood vessels. Without limitation, stroke is a well-known example of such a condition. Other such conditions include myocardial infarction, limb ischemia, occlusion or clotting of vascular grafts and bypass, and venous thrombosis.

  Stroke is often called a "brain attack". Stroke often results in rapid and significant loss of brain function due to disruption of the blood supply to the brain. As a result, the inability to exercise, verbal use, vision, and many other biological functions can be temporarily or irreversibly impaired. Stroke is either hemorrhagic (due to hemorrhage) or ischemic (due to inadequate blood supply). Most of the stroke is ischemic. In the United States, it is estimated that approximately 700,000 ischemic strokes occur each year. The main causes of ischemic stroke are thrombosis (coagulation) in the blood vessels supplying the brain or embolism from another source such as the heart leading to the blood vessels supplying the brain. Thrombosis can occur if there is an existing narrowing of blood vessels in the brain, usually from atherosclerotic diseases.

  Treatment of acute ischemic stroke has focused on reestablishing blood flow to the brain as soon as possible. Treatment includes the use of drugs such as tissue plasminogen activator (tPA), thrombolytic drugs (blood clot breaking drugs) and the like. More recently, devices such as the Stentriever device (Trevo, Stryker, Fremont, California; Solitaire, Covidien, Irvine, California) and aspiration thrombectomy catheters (Penumbra, Inc., Alameda, California) have been referred to for thrombectomy in acute stroke, Approved by the US Food and Drug Administration. These devices do not always achieve full reconnection. Sometimes these devices may not be able to open any of the blood vessels, or may only partially open the blood vessels. These devices may also take some time to function, requiring the device to pass multiple times into the intracranial circulation before the blood vessels reopen. In addition, the device may fragment the clot and cause some portion of the clot to be advanced distally by the cerebral circulation. There is a need for a device in which a high percentage of complete recanalisation is performed more quickly due to complete or partial clot capture.

  One aspect of the invention disclosed herein relates to a device for use in a body cavity. The device comprises a plurality of engagement elements comprising a central wire having its proximal and distal ends, a distal engagement element, a proximal engagement element, and one or more central engagement elements. And a plurality of engaging elements, each associated with the central wire. Each of the plurality of engagement elements may comprise its distal end and its proximal end. The distal engagement element is disposed most distally of the plurality of engagement elements and secured to the distal tip of the central wire, and the proximal engagement element is the most proximal of the plurality of engagement elements And one or more central engagement elements are disposed between the distal engagement element and the proximal engagement element. The device is a flexible connection wire associated with the proximal engagement element and the at least one other engagement element configured to position the associated engagement element at a distance. The method may further comprise a connection wire and a proximal end control element disposed proximal to the proximal engagement element, the proximal end of the proximal engagement element being fixed. .

  In some embodiments, the proximal end control element may comprise a tube section comprising its distal end and the proximal end, the proximal end of the proximal engagement element being around the distal end of the tube section It is fixed to

  In some other embodiments, the proximal end control element may comprise a control wire comprising its distal end and its proximal end, the proximal end of the proximal engagement element being the distal end of the control wire Fixed around the

  In yet some other embodiments, the proximal end control element may comprise a wire comprising its distal end and proximal end, the distal segment of the wire being flexible and acting as a connecting wire , All of the engagement elements are fixed to the connection wire.

  In still some other embodiments, at least one of the plurality of engagement elements may comprise a plurality of wires or struts.

  In still some other embodiments, the overall shape of the engagement element is conical, spherical, tubular, ellipsoidal, or any combination of the above structures.

  In still some other embodiments, the flexible connection wire is associated with each of the plurality of engagement elements at a preset distance.

  In yet some other embodiments, the flexible connection wires are associated with each of the plurality of engagement elements at equal distances.

  In still some other embodiments, at least one of the plurality of engagement elements is self-expanding.

  In still some other embodiments, at least one of the plurality of engagement elements comprises about 3 mm to about 25 mm for the length between the respective proximal end and the respective distal end.

  In still some other embodiments, at least one of the plurality of engagement elements has an open end at its distal end.

  In still some other embodiments, the degree of stiffness of each of the plurality of engaging elements is the same or different from one another.

  Furthermore, in some other embodiments, dimensions such as diameter and length of each of the plurality of engagement elements are identical or different from one another.

  In still some other embodiments, at least one of the plurality of engagement elements has a closed end at its distal end.

  Another aspect of the invention disclosed herein may relate to a device for use in a body cavity. The device comprises a central wire having its proximal and distal ends and a plurality of engaging elements comprising at least two pairs of engaging elements, each of the plurality of engaging elements being associated with the central wire And a plurality of engaging elements. Each pair of engaging elements may comprise a capture element and a receiving element, the capture elements being disposed distal to the receiving elements in each pair. The device is a spacing wire associated with the proximal element, the receiving element locating the associated proximal element and the receiving element in each pair at a distance And a proximal end control element disposed proximal to all of the engagement elements, the proximal end of the most proximal engagement element being fixed. .

  In some embodiments, the engagement elements in each pair operate together as a recovery unit.

  In some other embodiments, the proximal end control element may comprise a tube segment comprising its distal end and proximal end, the proximal end of the most proximal engagement element and the spacing wire May be fixed around the distal end of the tube section.

  In still some other embodiments, the proximal end control element may comprise a control wire comprising its distal end and its proximal end, with the proximal end of the most proximal engagement element being the control wire It may be fixed around the distal end.

  In still some other embodiments, the proximal end control element may be a wire comprising its distal end and the proximal end, the distal segment of the wire being flexible and spacing It may act as a wire and all of the receiving engagement elements may be fixed to the spacing wire.

  In still some other embodiments, at least one of the plurality of engagement elements may comprise a plurality of wires or struts.

  In still some other embodiments, the overall shape of the engagement element may be conical, spherical, tubular, ellipsoidal, or any combination of the above structures.

  In still some other embodiments, at least one of the plurality of engagement elements is self-expanding.

  In still some other embodiments, at least one of the plurality of engagement elements may comprise about 3 mm to about 25 mm for the length between the respective proximal end and the respective distal end.

  In still some other embodiments, at least one of the plurality of engagement elements may have an open end at its distal end.

  Furthermore, in some other embodiments, the degree of stiffness of each of the plurality of engagement elements may be the same or may be different from one another.

  Furthermore, in some other embodiments, dimensions such as diameter and length of each of the plurality of engagement elements may be the same or may be different from one another.

  In still some other embodiments, at least one of the plurality of engagement elements may have a closed end at its distal end.

  Yet another aspect of the invention disclosed herein relates to a device for use in a body cavity. The device comprises a central wire having its proximal and distal ends and a plurality of engagement elements comprising at least two pairs of engagement elements, each of which is associated with the central wire It may comprise a matching element. Each pair of engaging elements may comprise a capture element and a receiving element, the capture elements being disposed distal to the receiving elements in each pair. The device is a spacing wire associated with the proximal element, the receiving element locating the associated proximal element and the receiving element in each pair at a distance It may further be provided. One or more of the receiving elements may be fixed to the spacing wire using a freely slidable tube connector on the center wire.

  In some embodiments, the device may further comprise a connection wire secured between the capture element and the reception element of each pair of engagement elements.

  In some other embodiments, at least one of the plurality of engagement elements may comprise a plurality of wires or struts.

  In still some other embodiments, the overall shape of the engagement element may be conical, spherical, tubular, ellipsoidal, or any combination of the above structures.

  In still some other embodiments, at least one of the plurality of engagement elements may be self-expanding.

  In still some other embodiments, at least one of the plurality of engagement elements may comprise about 3 mm to about 25 mm for the length between the respective proximal end and the respective distal end .

  In still some other embodiments, at least one of the plurality of engagement elements may have an open end at its distal end.

  Furthermore, in some other embodiments, the degree of stiffness of each of the plurality of engagement elements may be the same or may be different from one another.

  Furthermore, in some other embodiments, the dimensions of each of the plurality of engaging elements may be the same or may be different from one another.

  In still some other embodiments, at least one of the plurality of engagement elements may have a closed end at its distal end.

  Still other aspects of the invention disclosed herein relate to a method of removing at least a portion of an occlusion from a first location within a body cavity. The method includes introducing a device according to some embodiments disclosed herein into a body cavity, placing the device around a first location, and at least a portion of the occlusion. Engaging with at least one of the engagement elements and removing the engaged occlusion from the first location may be included.

  In some embodiments, engaging pulls the central wire to engage a closure between one or more of the plurality of engagement elements and the at least two engagement elements. While holding the proximal end control element and / or adjusting by holding the central wire while pushing the proximal end control element to engage the occlusion between at least two of the engagement elements May include.

  In some other embodiments, engaging while pulling the center wire to engage the position of the receiving element and / or the capturing element between at least one pair of engaging units Holding the proximal end control element and / or adjusting by holding the central wire while pushing the proximal end control element to engage the occlusion between at least one pair of engagement units May be included.

  In yet some other embodiments, engaging adjusts the position of the capture element by pulling the central wire until at least a portion of the clot is engaged between at least one pair of engaging units May include.

FIG. 7 shows a non-limiting illustrative example of a device according to some embodiments of the present invention. In particular from the blood vessel according to some embodiments of the invention, showing another non-limiting illustrative example of the device, in particular when the device according to some embodiments of the invention is placed in a body cavity FIG. 10 shows some non-limiting examples of mechanisms for removing occlusion / clot. FIG. 7 shows yet another non-limiting illustrative example of a device, wherein the device according to some embodiments of the present invention comprises a plurality of engaging elements and connecting wires connecting the engaging elements. This device can be delivered to the body cavity via a microcatheter. This figure also shows that the device can be configured to be retrieved without the elements overlapping each other and returned to the microcatheter. FIG. 7 shows yet another non-limiting illustrative example of a device according to some embodiments of the present invention, wherein the device comprises a plurality of engagement elements. In this particular embodiment, the distal engagement element of the device may have a closed end at its distal end. Furthermore, the distal engagement element may be larger in size (length and diameter) than other engagement elements. However, the stiffness of the distal engagement element may be less than the stiffness of the other engagement elements to avoid vascular injury. FIG. 5A is a diagram illustrating yet another non-limiting illustrative example of a device, wherein the device according to some embodiments of the present invention comprises a plurality of engagement elements. 5B-5D illustrate the detailed location and structure of the proximal engagement element, the central engagement element, and the connector at the proximal end of the distal engagement element. 5B-5D also show the relationship between the connectors, control tube apartments, center wires, and connecting wires. FIG. 7 shows yet another non-limiting illustrative example embodiment of the device, wherein the device according to some embodiments of the present invention comprises a plurality of engagement elements. Non-limiting structures and components of the tube section, center wire handle, and connections between components are shown in this figure. FIG. 7 shows yet another non-limiting embodiment of the device, wherein the device according to the invention comprises a plurality of engagement elements. The device may further comprise a control wire, ie an alternative to the tube section. In the embodiment shown in FIG. 7A, the device comprises a connection wire and a control wire. The connection wire and the control wire may be joined at the proximal end of the proximal engagement element. The control wire may be operatively connected to the control wire handle at the proximal end of the device. FIG. 7B shows a particular non-limiting embodiment of the proximal connector that may connect the control wire, the connection wire and the legs of the proximal engagement element inside the proximal connector. Instead, in some of such embodiments, separate connection wires may not be necessary. Thus, as shown in FIG. 7C, the control and connection wires can be made from the same piece of wire, the connection wire sections / segments are small and flexible, and the control wire segments are somewhat larger It is possible. The control / connecting wire and the legs of the proximal engagement element may be joined via a connector. FIG. 8A shows yet another non-limiting embodiment of the device, wherein the device according to the invention comprises a plurality of engagement elements. Of the plurality of engaging elements, some of them are configured to function as receiving elements, while some others function as capturing / cinching elements Configured as. Each receiving element and capturing element form an engaging unit / pair. In certain embodiments, the receiving element may be associated with or connected to the spacing wire. The proximal end of the spacing wire and the proximal element are connected to the control tube segment. In some embodiments, a pair of receiving and capturing elements may function as an engaging unit / pair. In certain embodiments, the device may comprise multiple engagement units / pairs. FIG. 8A shows the engagement unit / pair open, and FIG. 8B shows the engagement unit / pair closed, ie the spacing between the capture engagement element and the reception engagement element is Show where it is shortened. Figures 8C-8F illustrate detailed connector structures and their relationship to control tube apartments, center wires, and spacing wires. FIG. 9 illustrates yet another non-limiting embodiment of a method according to the present invention in which the device shown in FIG. 8 is used to treat or remove one or more occlusions. 9A-9C illustrate one embodiment in which relatively large occlusions are removed by a device comprising multiple operating units / pairs. 9D-9F illustrate an embodiment in which multiple occlusions are individually removed by multiple operating units / pairs. FIG. 10 shows yet another non-limiting embodiment of the device, wherein the device according to the invention comprises a plurality of engagement elements, some of the engagement elements may function as receiving elements, but for engagement Some others of the elements may function as capture / grip elements. This figure shows the engagement element being pulled back to the microcatheter when needed during operation. FIG. 10 shows yet another non-limiting embodiment of the device, wherein the device according to the invention comprises a plurality of engagement elements, some of the engagement elements may function as receiving elements, but for engagement Some others of the elements may function as capture elements. In certain embodiments, a separate distal engagement element may be added to the tip of the central wire to capture clot debris that may be closed at its distal end. Furthermore, in some embodiments, the distal engagement element may be larger in size and diameter than other engagement elements. However, the stiffness of the distal engagement element may be less than the stiffness of the other engagement elements. FIG. 10 shows yet another non-limiting embodiment of the device, wherein the device according to the invention comprises a plurality of engagement elements, some of the engagement elements may function as receiving elements, but for engagement Some others of the elements may function as capture / grip elements. Additionally, the device may further comprise a control wire. The control wire may, in some embodiments, be operably connected at the proximal end of the device to a handle that allows the operator to manipulate the control wire, eg, to push or pull the control wire. All receiving elements are fixed to the spacing wire with a designed spacing between them and are free to move along the center wire. All capture elements are secured to the center wire. By controlling one or both of the control and center wires, the space between the engagement elements can be adjusted to maximize engagement and confinement of the occlusion by the device. 12A and 12B illustrate the adjustment of the space between the engagement elements. 12D-12E illustrate views of a particular non-limiting embodiment of the proximal connector. Fig. 6 shows a further alternative non-limiting embodiment of the device, wherein the device according to the invention comprises a plurality of engagement elements. In a particular embodiment, one engaging element and one capturing element, the two engaging elements form individual operating units / pairs. The device can comprise a plurality of engaging operation units / pairs. The receiving elements in different operating units / pairs can be associated with or connectable to the connection wires. Furthermore, in certain embodiments, the engaging elements within the same unit / pair (eg, at least one receiving element and one capturing element) may be connected to or associated with the spacing wire It may be done. FIG. 13B shows the device with a reduced space between the engagement elements. 13D-13F illustrate the relationship of the connectors with the engagement elements, connection wires, spacing wires, and center wires at various locations of the engagement section. FIG. 7 shows yet another alternative non-limiting and exemplary embodiment alternative structure of the engagement element. FIG. 10 shows yet another alternative non-limiting exemplary embodiment of a structure in which the engagement element can be made.

  The present disclosure relates generally to devices used in body cavities such as blood vessels and methods of using the same. In some embodiments, the device can be positioned within a body cavity to remove occluding material such as blood clots or foreign matter from the lumen. Some aspects of the invention provide devices and methods configured to treat conditions in blood vessels, including but not limited to stroke. In some embodiments, the devices and methods treat an ischemic stroke related condition by removing an occlusion / clot from a blood vessel and / or reopen the blood vessel to resume blood flow therein Configured as. Non-limiting examples of blood vessels may be surgically implanted grafts and bypasses that serve as components of the arteries, veins, or circulatory system.

  The terms "obstruction" or "clot" generally include anything that partially or completely blocks the lumen of a blood vessel. The occlusion / clot slows or blocks the flow (e.g., the flow of blood or any other biological fluid) flowing through the lumen. Examples of occlusions / clot may be blood occlusion / clot and atherosclerotic plaques present in blood vessels as well as fat or foreign matter.

  The term "stroke" generally includes conditions caused, in part, by disruption of the blood supply to the brain. This disorder can be caused by blockade (eg, ischemic stroke) and / or bleeding (eg, hemorrhagic stroke). In particular, ischemic stroke can be caused by partial or significant blockage of blood vessels. Treatment of ischemic conditions is applicable to blood vessels present in the brain as well as in other tissues such as the heart. Thus, the devices and methods disclosed in the present application are not limited for use in any particular organ, but of the body that would benefit from the removal of an occlusion / clot to restore blood flow. It is applicable to any blood vessel. In addition, the devices and methods according to the invention can be used to treat venous occlusions / clumps that can lead to other conditions besides ischemia.

  The device can be introduced into the blood vessel through a catheter or microcatheter. A "catheter" or "microcatheter" generally includes a tubular structure that is insertable into a body cavity, thereby allowing the administration of devices and / or chemicals to the area of the body requiring treatment.

  Moreover, many different modifications and alterations that would be apparent to one of ordinary skill in the art can be made without affecting the scope of the present invention, as appropriate to the particular treatment situation. Thus, not only the examples disclosed in the present application, but also such obvious modifications and alterations should be included within the scope of the present invention.

  One aspect of the invention relates to a device for use in a blood vessel comprising a plurality of engaging elements, control tube sections, center wires and / or control wires. The engagement element forms a self-expanding section. Blood vessel sizes vary very much, from about 0.03 inches (about 1 mm) diameter in smaller arteries and veins to 1.2 inches (about 30 mm) in the aorta. Thus, in some embodiments, when the device is in a deployed state, the diameter of the device may span approximately 0.01 inches (approximately 0.25 mm) to 1.2 inches (approximately 30 mm). In some other embodiments, the diameter of the device in the folded state is approximately 0.01 inches, approximately 0.02 inches, approximately 0.03 inches, approximately 0.04 inches, approximately 0.05 inches, approximately 0. .06 inches, approximately 0.07 inches, approximately 0.07 inches, approximately 0.08 inches, approximately 0.09 inches, approximately 0.10 inches, approximately 0.12 inches, approximately 0.14 inches, approximately 0.16 Inches, approximately 0.18 inches, approximately 0.20 inches, approximately 0.30 inches, approximately 0.40 inches, approximately 0.50 inches, approximately 0.60 inches, approximately 0.70 inches, or any of the above listed It may be between the values given.

  Another aspect of the invention relates to a device for use in blood vessels, comprising a microcatheter, a central wire, a tube component and an engagement section. The engagement section may comprise a distal engagement element, a central engagement element and a proximal engagement element. The engagement element is connectable to the connection wire and / or the spacing wire through the connector. In some embodiments, the distal engagement element can be associated with the center wire. The space between the engagement elements may be adjustable. In at least some embodiments, the space between adjacent elements is adjustable from approximately 0 to 50 mm. In certain embodiments, the distance between the engaging elements is adjusted to be approximately 0 mm, 5 mm, 10 mm, 15 mm, 20 mm, 25 mm, 30 mm, 35 mm, 40 mm, 45 mm, and 50 mm, and any range therebetween Good. In an alternative embodiment, the space between the engagement elements may be adjusted to more than 50 mm.

  In some embodiments, the device can be introduced into a blood vessel. Blood vessel sizes vary very much, from about 0.03 inches (about 1 mm) in smaller arteries and veins to 1.0 inches (about 25 mm) in larger arteries. Thus, in some embodiments, the diameter of the device may span approximately 0.01 inches (approximately 0.25 mm) to 1.0 inches (approximately 25 mm). Also, the diameter of the single device may change during operation when the engagement section is opened (i.e. deployed) or closed (i.e. folded).

  In some embodiments, the device further comprises a center wire. The central wire may pass through the tube component and move freely through it. In certain embodiments, the center wire is associated with the engagement section. More specifically, the central wire may be associated with the distal engagement element, the central element, the proximal engagement element. Association generally refers to any type of connection between two objects. As association, there is fixation. This is because movement of one object is impeded by another object when two objects are associated. In other words, when two objects are associated by means of fixation, the movements of the two objects are synchronized. However, the association does not necessarily indicate fixation of one object to another. Thus, when two objects are associated but not in a fixed state, the movement of one object relative to the other is not impeded. Thus, in at least some embodiments, the central element and the proximal engagement element may be associated with the central wire (eg, the central element and the proximal engagement element may pass along the central wire) , May move freely along the central wire.

  According to a particular embodiment, the central wire is fixed or joined with the distal engagement element. In some cases, the proximal or distal end of the distal engagement element may be joined to the distal end of the center wire. The association (i.e., connection) between the central wire and the distal engagement element may be made through various means such as welding, gluing or clipping on the connector. In some embodiments, the junction between the central wire and the distal engagement element is covered by a distal element connector. Alternatively, the connector may consist of a short outer connector tube and a short inner connector tube fixed between the walls of the tube and having components to be filled with joint media.

  In some embodiments, the center wire may comprise or be in the form of a wire, a blade, or a cable. The wire may have a uniform diameter or may have a tapered diameter that varies from the distal end to the proximal end. A variety of materials can be used to make the central wire, which may be metallic and non-metallic materials. Some non-limiting examples of metallic materials for the central wire include nickel, titanium, stainless steel, cobalt, chromium, and any of the foregoing, such as nitinol (NiTi) or cobalt chromium alloy Good. Furthermore, any polymer or plastic having the desired property of being a central wire can be used for its production. The polymer includes, but is not limited to, polyimide, PEEK (polyether ether ketone), nylon, PTFE (polytetrafluoroethylene), PET (polyethylene terephthalate), polypropylene and the like. Polymer coated metals including but not limited to PTFE coated stainless steel or PTFE coated NiTi can also be used as the central wire. Also hydrophilic coatings are applicable. Such a coating is partially applicable to reduce the friction between the central wire and the tube section. The central wire can also be made from composites such as PTFE or FEP (fluorinated ethylene propylene) tubes on NiTi wires, or PTFE or FEP tubes on stainless steel. The diameter of the center wire may range from approximately 0.001 inches to 0.1 inches. In particular embodiments, the diameter of the center wire is about 0.001 inches, about 0.002 inches, about 0.003 inches, about 0.004 inches, about 0.005 inches, about 0.006 inches, about 0. It may be .007 inches, about 0.008 inches, about 0.009 inches, about 0.01 inches. Alternatively, the diameter of the center wire may be greater than 0.01 inches.

  The term "engagement compartment" is generally compressed to a small profile / diameter, reinserted into a body cavity through a microcatheter, and re-compressed to close a sealed lumen or blood vessel. Deploys to a large diameter and includes an elastic structure capable of engaging and removing at least a portion of a clot / occlusion. The engagement section may comprise a distal engagement element, a central engagement element and a proximal engagement element. In some embodiments, the engagement element may comprise a plurality of wires. The engagement element can be formed into a mesh or blade structure in at least some embodiments. In some other embodiments, the engagement element may comprise a strut made of tubing or sheet material. The struts can be made of laser cut hypo tube material or sheet material, or photo etched sheet material. Heat treatment may be required to set the struts to the desired shape, eg conical or cylindrical, followed by chemical etching or electropolishing in order to smooth the surface of the element.

  The engagement element can be made of an elastic material. Some non-limiting examples of such metallic materials for engaging elements are nickel-titanium (NiTi) alloys, stainless steel, titanium and its alloys, and cobalt chromium (CoCr) alloys. Alternatively, any polymer or plastic having desirable properties for the distal engagement element can be used. In a further alternative, the engagement element can be constructed using two or more different materials, such as a polymer coated metal material.

  In some embodiments, the overall all diameter of the engagement element may vary from approximately 1 to 8 mm in its deployed state. In certain embodiments, the diameter of the distal engagement element in the deployed state may be approximately 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, and 8 mm, or any range therebetween. In some other embodiments, the length of each engagement element may vary from approximately 2 to 40 mm. In certain embodiments, the length of each engagement element is approximately 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 8 mm, 10 mm, 15 mm, 20 mm, 25 mm, 25 mm, 30 mm, 35 mm, or 40 mm, or between It may be in any range of Further, in an alternative embodiment, the length of each engagement element may be greater than 40 mm.

  In some embodiments, markers may be added to the device. Such markers may include radiopaque materials that help monitor the position and / or movement of the device within the body. Some non-limiting examples of radiopaque markers may include gold, gold alloys, CoCr alloys, platinum or platinum alloys. The marker can also be in the form of a radiopaque coating. Markers may be added anywhere in the device. In some embodiments, one or more markers may be added at the distal engagement element such that the location of the distal engagement element within the body is determined. In some embodiments, one or more markers may be added at the proximal engagement element such that the location of the proximal engagement element within the body is determined. In yet some other embodiments, any or all of the engagement elements may include a marker. Alternatively, one or more markers may be added to the center wire and / or tube section. In some embodiments, the markers may be approximately 0.10 to 4 mm in length and approximately 0.001 to 0.030 inches in diameter. However, any variation of any dimensions (e.g., length, diameter, size, and mass) and shape of the marker is suitable.

  In some embodiments, the device may comprise one or more tube sections. The control pipe section may comprise a plurality of pipe elements. Such tube elements may include pusher tubing and connecting tubes. In at least some embodiments, the pusher tube may further comprise an inner pusher tube, an outer pusher tube, and / or a proximal pusher tube, and a distal pusher tube. These push tube components may be attached to one another or fixed to one another. Various materials can be used to make the tube element, and various materials can be metallic and non-metallic materials. In some embodiments, the distal pusher and / or the outer pusher can be made of a lubricious and flexible polymer, such as PTFE or PET. When stretch resistance is required, relatively small polyimide or PEEK tubes may be utilized. The proximal pusher tube can be made of nitinol superelastic material, stainless steel, CoCr alloy, titanium alloy, or polymers (polyimide, PEEK, etc.). In order to reduce the friction between the pusher tube and the inner lumen of the microcatheter, one or more of the tube elements can also be coated with a lubricious material such as a PTFE coating, a hydrophilic coating or the like. The tube elements can also be made from composites such as PTFE or FEP (fluorinated ethylene propylene) tubes on metal (Nitinol, stainless etc) coils, for the purpose of pressability and flexibility.

  The center wires, control wires, spacing wires, and connecting wires can be in the form of wires, blades or cables. Some non-limiting examples of metallic materials for the central wire are nickel, titanium, stainless steel, cobalt, chromium, and any of the aforementioned alloys such as nitinol (NiTi), titanium alloys, or cobalt chromium alloys May be included. Furthermore, any polymer or plastic having the desired property of being a central wire can be used for its production. The polymer includes, but is not limited to, polyimide, PEEK (polyether ether ketone), nylon, PTFE (polytetrafluoroethylene), PET (polyethylene terephthalate), polypropylene and the like. Polymer coated metals including but not limited to PTFE coated stainless steel or PTFE coated NiTi can also be used as the central wire. Also, a hydrophilic coating may be applied to reduce friction between the wire and the inner lumen of the pusher tube.

  In some embodiments, the outer diameter of the push tube component may be approximately 0.001 to 0.050 inches. In other embodiments, the diameter of the push tube component may be less than 0.001 inches or greater than 0.050 inches.

  In some embodiments, the device may comprise multiple engagement elements, such as two, three, four, five, six or more engagement elements. Thus, in embodiments where three or more engagement elements are present in the device, the distal engagement element disposed most distally of all the engagement elements, the proximal engagement element disposed most proximally There may be an engagement element and one or more central engagement elements disposed between the distal engagement element and the proximal engagement element.

  The shape, size, and structure / configuration of the engaging element is not limited and can be varied to a degree compatible with the blood vessel and suitable for treatment. In certain embodiments, the engagement element is generally conical or pyramidal (shown in FIG. 14A), cylindrical or tubular (FIG. 14C), oval (FIG. 14D), or spherical (FIG. 14D), Or can be shaped into an umbrella (or parachute) shape or the like (FIG. 14E), and any combination of the shapes / shapes described above. An example is shown in FIG. 14B. The engagement element may be open or closed at both ends when it is cylindrical or tubular in shape. The individual engagement elements present in the same device may, for example, differ from one another in terms of size, structure, material and / or function. Alternatively, some or all of the engagement elements present in the same device may share one or more common features therein, eg, size, structure, material and function.

  Furthermore, in some embodiments, there are connection wires associated with two or more of the engagement elements of the device. In some embodiments, the connecting wire may connect or be associated with certain or some (not all) of the plurality of engaging elements. In some other embodiments, the connection wire may be associated with or connected to all of the engagement elements present in the device. The association or connection between the connection wire and the individual engagement elements may be fixed at one position of the connection wire. When multiple engagement elements are associated with (or connected to) the connection wire, the type of association / connection of the individual engagement elements with the connection wire, for example the fixed or non-fixed manner, It may change within one device. Thus, in some embodiments, some (but not all) of the engagement elements associated with or connected to the same connection wire may be fixed at each position of the connection wire. The connecting wires may be flexible or floppy, which may reduce the space between the engagement elements when it is desired to reduce the distance between the engagement elements. In these circumstances, the connecting wire may be stretch resistant while under tension, such that the maximum distance between the engaging elements is also limited by the connecting wire.

  The association (i.e. connection) between the connection wire and the engagement element, in particular the fixation (or bonding) between them, may be performed via various means such as welding, gluing or clipping. Additional elements such as tubes or connectors can be present if the engagement element and the connecting wire are fixed to it. The association (i.e. connection) between the connection wire and the engagement element takes place via various means (e.g. a connector) including a connector, in particular if the engagement element can move along the central wire It is possible. For example, the engagement elements may include or be attached to short inner element connector tubes and outer element connector tubes. A connecting wire may be attached between the walls of the two tubes, and a center wire may pass through (internal to) the inner element connector tube. Thus, the engagement element can move (slide) along the center wire without being fixed in a particular position.

  In some designs, spacing wires may also be present. The engagement element is fixable to the spacing wire. Spacing wires may be somewhat stiffer than connecting wires and thus will not bend or sag. Thus, the spacing wires maintain a fixed space or distance between the engagement elements.

  The connecting wires and / or spacing wires can be in the form of round or flat wires, cables or have a blade structure. The connecting wire is flexible but stretch resistant in some embodiments. Some non-limiting examples of metallic materials for connecting wires are nickel, titanium, stainless steel, cobalt, chromium, and any of the aforementioned alloys such as nitinol (NiTi), titanium alloys, or cobalt chromium alloys May be included. Furthermore, any polymer or plastic having the desired properties of being a connecting wire can be used for its production. The polymer includes, but is not limited to, polyimide, PEEK (polyether ether ketone), nylon, PTFE (polytetrafluoroethylene), PET (polyethylene terephthalate), polypropylene and the like. Polymer coated metals including but not limited to PTFE coated stainless steel or PTFE coated NiTi can also be used as the connecting wire. Also hydrophilic coatings are applicable.

  In certain embodiments, multiple connection wires can be present. In some of such embodiments, the connecting wire may be associated with or connected to all of the engagement elements present in the device. Alternatively, the connecting wire may be associated with or connected to the pair of engagement elements, ie, the receiving engagement element and the capture engagement element. In certain embodiments, there may be two, three, four, five, six or more connection wires present in a single device. In some other embodiments, the device can have seven or more connection wires.

  In some embodiments, the device comprises a proximal end control element that can be associated with the most proximally disposed engagement element and capable of controlling the position of the associated engagement element You may In certain embodiments, the proximal end control element can be in the form of a tube segment or a wire. The proximal end control element can set the boundary of the most proximal end of the engagement element. In certain embodiments, the proximal end control element may be operably coupled to a handle that can control movement of the proximal end control element.

  In some embodiments where the device comprises a plurality of engagement elements, the device may further comprise a tube section associated with (or connected to) the proximal engagement element of the device. In some embodiments, other engagement elements other than the proximal engagement element are either connection wires or spacing wires (both are between the proximal engagement element and the other engagement element). It can be associated with (or connected to) the tube via (which can help maintain the desired space). In some embodiments, the proximal engagement element is fixable around the distal end of the tube segment via its proximal end connector. Thus, in such embodiments, the movement of the proximal engagement element and other elements fixed to the connection or spacing wire is controlled by the tube section.

  In alternative embodiments, the device may comprise a plurality of engagement elements, and may also comprise control wires associated with (or connected to) one or more engagement elements of the device. In some embodiments, a control wire may be associated with the proximal engagement element of the device. The association (or connection) between the control wire and the proximal engagement element may comprise a fixation or joint in which the engagement element is fixed at a position of the control wire. Thus, the movement of the proximal engagement element is controlled by pushing or pulling on the control wire.

  In certain embodiments in which a plurality of engagement elements are associated with the control wire, each of the associated engagement elements is fixable at its respective position on the control wire. In some embodiments where multiple engaging elements (receiving elements) are associated with the control wire, some, but not all, of the associated engaging elements are controlled via the engaging element connector tube Fixed in their respective position on the wire or spacing wire. These engagement elements can move along the center wire to change the space between the receiving element and the capture element.

  In some embodiments, the control wire controls (or actuates) the control wire through the handle, eg, the proximal end of the device, so that an operator (eg, a practitioner) can control (or activate) the control wire. Are operatively connected or connected to the handle at This control action, which controls the movement of the control wire, becomes the control of the movement of the control wire and the engagement element associated with the spacing wire.

  The control wire can be in the form of a wire, a cable, a blade or a tube. Some non-limiting examples of metallic materials for connecting wires are nickel, titanium, stainless steel, cobalt, chromium, and any of the aforementioned alloys such as nitinol (NiTi), titanium alloys, or cobalt chromium alloys May be included. In addition, any polymer or plastic having the desired properties of being a control wire can be used for its production. The polymer includes, but is not limited to, polyimide, PEEK (polyether ether ketone), nylon, PTFE (polytetrafluoroethylene), PET (polyethylene terephthalate), polypropylene and the like. Polymer coated metals including but not limited to PTFE coated stainless steel or PTFE coated NiTi can also be used as control wires. Also hydrophilic coatings are applicable.

  In some embodiments, individual engagement elements are associated with (or to) one or more of the wires selected from the group consisting of control wires, connection wires, spacing wires, and center wires. Connection is possible. Furthermore, when an individual engagement element is associated with (or connected to) at least two of the wires, the engagement element is movable along the other associated / connected wires While, it can be fixed at a certain position relative to at least one of the associated / connected wires. Thus, for example, the engagement element may still be movable on the other wire if it is associated with the control wire or spacing wire, ie fixed to the control wire or spacing wire.

  Individual engagement elements associate with such wires by controlling one or more of one or more wires (eg, control wires, connection wires, spacing wires, and center wires) When being (or connected to) the position of the individual engagement elements is controllable. Furthermore, the spacing or distance between the engagement elements can also be adjusted via control of the associated / connected wires, respectively. Thus, while engaging and involving the occlusion with the device to remove or treat the occlusion from the body cavity, the operator operates the single engagement element or two or more engagement elements into the operating unit Can be launched as a / pair. This complex and fine mode of operation significantly improves the efficiency of the treatment while minimizing the risk of damaging the body cavity.

  The control wire (or tube section) is separate from the central wire and not attached to it, and may therefore move independently. In some embodiments, there is a separate proximal handle configured to control the control wire or tube segment and the central wire. These handles act as controllers. By operating these handles and controlling the center and control wires or tube segments, the individual engagement elements of the device can be positioned at the desired location and also the grasp / capture of the occlusion from the body cavity The space / distance between two or more of the engagement elements is adjustable to maximize removal. Alternatively, or in combination with the control wire or tube segment, and the center wire, the connection wire and / or the spacing wire in certain embodiments may control the space or distance between two or more engagement elements. It is possible. For example, the connection wires may be separate and move independently of the center and control wires. Thus, the connection wires may allow to reduce the space / distance between the one or more engagement elements. When the central wire is pulled proximally or the control wire or tube segment is pushed distally, the space between the receiving element and the capturing element is shortened to grip or hold the clot. While pulling the control wire or tube section proximally and holding the central wire, the distance between the capture element and the receiving element increases until the connecting wire is tensioned. This allows the components of the engagement section to be retracted into the microcatheter without the elements overlapping each other.

  In some embodiments, the device comprises two or more engagement units / pairs in which four or more engagement elements operate together to capture / grip an occlusion and remove it from the body cavity You may In a particular embodiment, the engagement unit / pair may comprise two engagement elements, one acting as a receiving element and the other an engaging element acting as a capture element. In some embodiments, within the engagement unit / pair, the capture element can be disposed distally while the reception element can be disposed proximally. The capture element may be configured to be capable of engaging (eg, capturing or gripping) an occlusion. The capture element can be in direct engagement with the occlusion along any part of the strut that contacts the occlusion using its proximal end of the element body or by its wire / strut structure. Alternatively, the occlusion can be frictionally engaged between the body cavity and the capture element. Still alternatively, the occlusion can be captured, gripped or held between the capture and receiving elements. All of these mechanisms for catching, engaging, firmly gripping or holding an occlusion may act simultaneously to engage and remove the occlusion, eg, the part with the occlusion may be a capture element and There may be frictional engagement with the body cavity (between the capture element and the body cavity) and some other portion of the occlusion may be engaged with the receiving element. There may be multiple modes of engagement capture and occlusion using occlusion elements and body lumens, any such variation being within the scope of the methods and devices disclosed herein. Is included.

  In certain embodiments, the distal engagement elements form a mesh so that occlusions can be captured, either alone or in combination with another proximally disposed engagement element or receiving element and / or a body cavity. Wires or struts may be provided. The more proximal engaging or receiving element can also allow direct engagement with the occlusion if desired or necessary via its wires or struts, but for more distal engagement The element or capture element can also function to assure or enhance engagement of the occlusion. For example, in certain cases where the occlusion is relatively large or extends a distance along the body cavity, multiple engagement elements or multiple capture and reception elements (and often with frictional engagement with the body cavity) Can act to engage the occlusion at multiple locations to ensure more complete engagement of the clot. See, for example, the non-limiting and exemplary embodiments shown in FIGS. 2B and 9A-9C. Alternatively, the individual engagement (or operation) units / pairs operate separately to remove a separate occlusion. See, for example, the non-limiting exemplary embodiments shown in FIGS. 9D-9F. Also or alternatively or in combination with at least one of the aforementioned modes, the receiving element or more proximal engagement element is a capture element or more distal engagement which holds or firmly grips a clot between two adjacent elements The access element can be approached, which can result in more complete or stronger capture of the occlusion. In certain embodiments, the proximal engagement or reception element may be shaped to be compatible with the more distal engagement or capture element proximal portion. In other words, the proximal portion of the distal engagement or capture element may mate with the distal portion of the more proximal engagement or reception element. Thus, confinement of the occlusion between the two elements can be further ensured during the treatment procedure and also during removal of the device from the lumen.

  In some embodiments, the device can comprise more than two operating units / pairs. Thus, in particular embodiments, the device may comprise three, four, five, six or more operating units / pairs. In certain embodiments, the distal end of the distal engagement element or device may not completely exceed the occlusion in the body cavity. Rather, the device may advance to only a portion of the proximal end of the occlusion and engage only a portion of the occlusion, as shown, for example, in FIGS. 9A-9F. For example, it may be difficult or impossible to visualize how long the blockade (occlusion) extends in the lumen, ie where the distal end of the occlusion is. In these situations, it may be determined that it is safer to advance the device by, or within, only a portion of the occlusion and to engage only that portion of the occlusion. However, in some other cases this may be done when it is determined that advancing the device beyond the distal end of the occlusion may be a safe operation.

  In some embodiments, the position of the individual engagement elements or the position of the operating unit / pair is selected from the group consisting of center wire, control tube / wire section, connection wire, spacing wire, and control wire It is adjustable via the movement of at least one thing. In general, all engaging elements in the device may be associated with (or connected to) the center wire. In some embodiments, only some (but not all) of the engagement elements may be fixed in their respective positions on the center wire, but some other engagement elements are still on the control wire It may be movable along. In certain embodiments, all capture elements (from different operating units / pairs) of the device may be fixed at their respective positions in the center wire, but all reception elements move along the center wire It may be possible.

  For the purpose of illustration, several non-limiting and illustrative examples of devices according to the present invention are provided in the following figures. Although only a few exemplary applications are described herein for the purpose of illustration, numerous different modifications and alterations that would be apparent to one of ordinary skill in the art are also within the scope of the present invention. It is possible to be Thus, not only the examples disclosed in the present application, but also such obvious modifications and alterations should be included within the scope of the present invention.

  FIG. 1 illustrates one embodiment of a device where the device may comprise a plurality of engagement elements. In some embodiments, the device may comprise more than two engagement elements. In some embodiments, the device may comprise a central wire (10), a tube section (27), three or more engaging elements (65, 67, 90) and a connecting wire (190) . This figure shows four engagement elements including a distal engagement element (90), a proximal engagement element (65) and two central engagement elements (67). In this example, the most distal engagement element (90) functions as a capture element, and all the engagement elements in the proximity may function as a capture element and / or a reception element. The individual engagement elements may vary in length by 3 to 25 mm when extended. FIG. 1A is in its open state, ie, the space between each adjacent engagement element is completely open, and the length of the space is marked “d”. FIG. 1B shows that in the closed state, the space between each engagement element is shortened (from “d” to “d1”) in order to hold, firmly grip or grip the occlusion or clot.

  In some embodiments, all the plurality of engagement elements (65, 67 and 90) are associated with (or connected to) the center wire (10). Of these, the proximal end of the distal engagement element (90) can be fixed to the distal end (or tip) of the central wire (10) while the other three engagement elements (65 and 67) are , Can slide freely on the central wire. Also, all the plurality of engagement elements can be associated with the connecting wire (190). In some embodiments, the flexible connection wire (190) can connect the proximal ends of all the engagement elements with a preset or equal space between them. In such embodiments, the engagement elements are fixed in their respective positions on the connecting wire and maintain their distance using a specific operation. Furthermore, in some embodiments, the proximal end of the proximal engagement element (65) is fixable to the distal end of the tube section (27). The central wire can slide freely inside the tube section. In certain embodiments, the device may further comprise a handle (110) at the proximal end of the device to be able to control (eg, push or pull) the center wire May be operably coupled to

  FIG. 2 shows another embodiment of the method in which a device comprising multiple engaging elements, such as the engaging elements shown in FIG. 1, is used to remove or treat an occlusion / clot in a body cavity.

  In some embodiments, the device can be introduced into the blood vessel through the microcatheter (30). Once the occlusion site in the body cavity is reached and the device is pushed through the microcatheter, the distal engagement element (90) may be initially pushed forward with the central wire. Continued pressure on the center wire maintains the connection wire in tension and pulls each engagement element associated with the connection wire forward along the microcatheter lumen. In addition, continuing the forward pressure while retracting the microcatheter allows the operator to expose the device and maintain the set distance between the engagement elements. The connecting wires can be flexible but are not generally extensible, so that the engaging elements can come close to one another when slack, but when the engaging elements are under tension , To prevent separation longer than a preset distance. The engaging elements, when exposed from the microcatheter, are positioned at a preset distance therebetween.

  When exposed, the central wire (10) can be held stably such that the distal engagement element (90) fixed at the distal end of the central wire can be stabilized. Friction between the inner lumen of the microcatheter and the surface of the engagement elements (65 and 67) can move the freely sliding engagement elements back. However, since the connecting wires are not stretchable, they maintain a preset space between each element. After exposure, the engagement element may self-deploy. The operator can adjust the space between the engagement elements. In order to engage or hold the clot, the operator (i) pulls the central wire backwards (ie proximally) while holding the tube section (27) steady (ii) ) For engagement by pushing the tube section forward (ie, distally) while holding the central wire in a stable manner, or (iii) pulling the central wire backwards to push the tube section forward The space between elements may be shortened. By adjusting the position of the engagement elements and the space between them, at least a part of the clot can be compressed / held firmly or captured in the space gap. See, for example, FIGS. 2B and 2C. Alternatively, or in combination, the occlusion may be immobilized via frictional engagement with the body cavity and one or more engagement elements. The occlusion can also directly engage the wire or struts of the engagement element. Also, the occlusion may be immobilized and captured between the one or more engagement elements and the body cavity. See also, for example, FIGS. 2B and 2C. In some embodiments, occlusion engagement (capture) and confinement may involve multiple modes. Thus, for example, at least a portion of the occlusion may be captured by direct engagement with one or more engagement elements, and at least some other portions of the occlusion may also be spaces of two or more engagement elements May be captured between Also or alternatively, any part of the occlusion may be frictionally trapped and immobilized by the body cavity and the engagement element.

  In some embodiments, it is possible to pull the central wire proximally while holding the tube segment during the treatment procedure. The distal engagement element may then be moved backwards to securely grasp or hold the clot using the adjacent engagement elements. The proximal engagement element and / or its adjacent engagement element is then pushed rearward (ie, proximally) by the compressed clot, which in turn compresses the occlusion and grips it firmly. The operator can reduce the distance between the engagement elements until the occlusion is securely gripped / held by the device. As a mode of securely grasping / grasping the occlusion, (1) the occlusion may be firmly grasped or held between the engagement elements (2) the occlusion may be a wire or wires of one or more engagement elements The occlusion may be directly engaged with the struts, (3) the occlusion may include friction between the body cavity and one or more of the engagement elements, and (4) the occlusion may be between the body cavity and the engagement elements There may be one or more of which may include friction with the space.

  The device may then be pulled out of the body cavity if the occlusion is deemed to be safely gripped or firmly gripped by the device. In some embodiments, such as the embodiments shown in FIGS. 1B and 2C, the connecting wires may be thin and flexible, and thus curl when the distance between the engagement elements is reduced. You can or bow.

  FIG. 3 shows another embodiment of the device wherein the device may comprise a plurality of engagement elements. In some embodiments, when the device needs to be retracted into the microcatheter (30) during a search procedure, the tube section (27) can be pulled backwards. The proximal engagement element (65) fixed to the tube section can be pulled into the microcatheter (30). When the connecting wire (190) is maintained in tension, the connecting wire (190) pulls the engagement elements connected to the connecting wire one by one into the microcatheter. The retrieval mechanism prevents multiple engagement elements from being stacked on top of one another so that the connecting wires can be extended to a preset distance between the engagement elements and pulled into the microcatheter Becomes possible. The stacked engagement elements may not fit into the microcatheter because they have too large a diameter and may also be damaged when pulled into the stacked position.

  FIG. 4 shows yet another embodiment of the device where the device may comprise a plurality of engagement elements. In some embodiments, the device may further comprise a distal engagement element (90) that may also function as a distal filter. In certain embodiments, the distal end (or tip) of the distal engagement element is closable by the distal connector (150). In some embodiments, the outer profile of the distal engagement element (90) may be larger in size (length and diameter) than the outer profiles of the other engagement elements and less rigid than the other engagement elements. This makes it possible to minimize the radial force of the distal engagement element against the vessel wall. This distal engagement element, particularly in the form of a distal filter, can prevent clot debris from flowing downstream. If clots (or occlusions) fragment during the treatment procedure to produce debris, the debris can be captured (collected or included) by the distal filter element (90) . Since the outer profile of the distal engagement (filter) element is large, preferably slightly larger than the diameter of the blood vessel in the retrieval path, strips can be avoided between the engagement element and the wall of the blood vessel It does not have to be. In this embodiment, the distal engagement element may also function to grip or hold the clot tightly with the more proximal adjacent engagement element.

  Furthermore, in certain embodiments, the proximal or distal end of the distal engagement element is securable to the central wire (10). Also, flexible connection wires (190) may be enabled to couple (associate or connect) other engagement elements. In some of such embodiments, all of the engagement elements are fixed in their respective positions on the connecting wire (190), thereby setting the space between each engagement element. In some embodiments, the proximal engagement element (65) is fixable around the distal end of the tube section (27). In this configuration, the position of the proximal engagement element is also adjustable when the tube section (27) is pushed or pulled. When the connecting wire is tensioned, the central engagement element can be pulled proximally by the tube section and pushed distally by the central wire.

  In some other embodiments, all engagement elements are associated with (or connected to) the center wire (10). In certain embodiments, only some (but not all) engagement elements are fixed to the center wire, but some other engagement elements can move freely on the center wire. Thus, for example, the distal engagement element (90) of FIG. 4 can be fixed at a certain position of the central wire while the proximal engagement element (65) and the central / intermediate engagement element (67) are central It can slide freely on the wire. In this configuration, the distal engagement element can be further controlled by the operator by pushing or pulling on the central wire through the handle (110), which allows the most distal extent of the device to be positioned. Once the distal engagement element is positioned, the operator controls the connection wire (190) via control of the tube section (27) to position the other engagement elements and the distance between the engagement elements / Space can be further adjusted.

  5A-5D illustrate the detailed structure, in particular the connector of the device, according to some embodiments of the present invention. FIG. 5B shows that the proximal engagement element is secured to the distal end of the tube section by a connector (41) consisting of an outer connector tube (43) and an inner push tube (21). The connection wire (190) and the legs of the proximal engagement element (40) are fixed / bonded between the walls of the two parts of the tube by means of the bonding medium (42). Similarly, FIG. 5C shows a central engaging element connector (44). The connection wire (190) and the legs of the central engagement element (40) are fixed / bonded between the walls of the two connector tube parts by means of the bonding medium (42). FIG. 5D shows that the distal connector (80) uses the short outer connector tube (43) filled with bonding medium (42) to form the distal tip of the central wire (10), the connecting wire (190), and the distal wire. Figure 16 shows joining the legs (40) of the positioning engagement element (90). The central wire (10) passes through the hollow space of the inner connector (21 and 45), allowing the proximal and central engagement elements (65, 67) to slide freely on the central wire Do.

  FIG. 6 shows a non-limiting exemplary structure of a pipe section according to some embodiments of the present invention. This tube section may comprise or consist of three main components: an inner distal pusher (21), an outer distal pusher (23) and a proximal pusher (25) . All are connected / connected by the bonding medium (42). This figure also shows that the proximal end of the center wire is joined to the handle (110) by the joining medium (42). The distal pusher tube (21, 23) is generally flexible to allow the device to pass through serpentine segments of blood vessels. The proximal pusher tube (25) is rigid to ensure that the device can be pushed through the microcatheter.

  7A-7C illustrate yet another embodiment of a device where the device may comprise multiple engagement elements. In some embodiments, the device may comprise a center wire (10), a control wire (100), and a plurality of self-expanding engagement elements, each of which is about 2 from the longitudinal direction It can be about 25 mm long or longer. The lengths of the individual engaging elements when deployed may be about 1 mm, about 2 mm, about 4 mm, about 5 mm, which may be the same as, similar to, or different from one another. About 6 mm, about 7 mm, about 8 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, about 20 mm, about 20 mm, 21 mm, 22 mm, 24 mm, And 25 mm. In some embodiments, the lengths of the individual engaging elements when deployed may be about 25 mm or more, which may be identical to, similar to, or different from one another. be able to.

  The proximal end of the distal engagement element (90) can be fixed around the distal end of the central wire (10) and the structure of the connection is the same as that already shown in FIG. 5D . The proximal end of the proximal engagement element (65) and the connecting wire (190) are close together consisting of the outer connecting tube (43), the inner connecting tube (45) and the bonding medium (42), as shown in FIG. 7B. A stationary end connector (41) is fixable around the distal end of the control wire (100). The center / engagement element is fixed to the connecting wire (190) via the connector 44 shown in FIG. 7C, the structure of the connection being the same as FIG. 5C and already described above in FIG. 5C. The proximal connector (41) and the central connector (44) can slide freely on the central wire (10). In some embodiments, thin flexible connection wires (190) connect the proximal ends of all the engaging elements at a preset or equal spacing / distance between each adjacent element. In certain embodiments, the distal segment of the control wire may be gradually tapered to a thinner, more flexible section to serve as a connecting wire. In such case, the proximal end of the proximal engagement element can be directly joined to the control wire where the thin section begins (i.e., the connecting wire 190 is one of the control wires 100, as shown in FIG. 7C). Segments / parts). The control wire (100) may have a handle (120) attached to the proximal end of the device. The central wire can slide freely inside the handle tube and the connector at the tip of the control wire as well as the central connector. Additionally, the device can have a separate handle (110) that can control the movement of the center wire.

  In some embodiments, all the engaging elements are fixed at their respective positions on the connecting wire (100), thereby setting a preset space / distance between them. On the other hand, all engagement elements can be associated with (or connected to) the central wire (10), but only the distal engagement element (90) may be fixed to the central wire (10), Other engagement elements may be able to move freely along the center wire. In some of such embodiments, controlling one or both of the central wire and the control wire may cause the position of each distal engagement element and the proximal engagement element and the space between them to occlude / clot. Can be adjusted to securely grip or grip the

  8A-8F illustrate yet another embodiment of a device where the device may comprise a plurality of engagement elements. In some embodiments, the device may comprise multiple engagement elements, some of which may form an engagement (or operation) unit / pair. The receiving element is connected with the spacing wire (191), which may be more rigid than the connecting wire (190) described above. The spacing wire is not flexible or soft, so it can not fold / bent under compression and therefore remains elongated. FIG. 8A shows that the distance between the receiving engagement element and the capture engagement element is fully open, and FIG. 8B shows that the space is shortened. 8D, 8E and 8F respectively show the detailed structure of the proximal receiving engagement element connector (41), the central capture engagement element connector (44), and the distal capture engagement element connector (80). Indicates In some embodiments, the device may comprise a central wire (10), a tube section (27) and a plurality of operating units / pairs. In some embodiments, the device may comprise two or more pairs of self-expanding engagement elements that grip the clot tightly (each pair comprising 68 and 69 is considered as one working unit / pair ). In each operating unit / pair, at least one is a receiving element (e.g., a proximal receiving element and a central receiving element (68)) and at least another engaging element is a capturing element (e.g., a central capturing element) There may be at least two or more engagement elements, which are the distal capture element (69)).

  In certain embodiments, the capture element may comprise a plurality of wires or struts directly engageable with the occlusion. Alternatively, or in combination, the capture element may block the occlusion via frictional engagement with the body cavity and / or within the space between the capture element and the other engaging (receiving or capturing) element. It can be firmly gripped or gripped. The capture element, in at least some embodiments, has a closed end at its proximal end. The open end of the capture element can face either the distal or the proximal side of the device. In some embodiments, all of the capture elements (from different operating units / pairs) are securable to the central wire (10) via the connectors (47, 80) and the receiving elements are 41, 44) are secured to the spacing wire (191), but the capture element may not be connected to the spacing wire. The receiving element is positionable proximal to the capture element and may be shaped to conform to the shape of the capture element at its distal end. Thus, in some embodiments, the proximal portion of the capture element can fit within the distal portion of the proximally disposed receiving element.

  In certain embodiments, the most proximally disposed receiving element (68) may be secured to the distal end of the tube section (27). Furthermore, all receiving elements can also be fixed at the respective position of the spacing wire (191). Thus, spacing wires may connect all receiving elements (68) and maintain the distance between the receiving elements. Thus, in such an arrangement, by controlling the tube sections, the position of all receiving elements while maintaining the distance between them by the preset distance set by the association with the spacing wire Is also controllable.

  In some embodiments (some or all of the capture elements from different operating units / pairs can be fixed to the central wire (10). The central wire is internal to the tube section (27) as well as It can slide freely inside the connector of the receiving engagement element, in this configuration the position of all the acquisition elements can be controlled via the movement of the central wire.

  Thus, in some embodiments, the position of the engagement element can be controlled by movement of the center wire and / or the tube segment. For example, the space between the receiving element and the capturing element can be controlled by sliding the central wire within the pipe section. Alternatively or in combination, the pressing or pulling of the tube section can also lead to an increase or a decrease in the distance between the receiving element and the capturing element.

  FIG. 9 shows yet another non-limiting embodiment of a method according to the present invention in which the device shown in FIG. 8 is used to treat or remove one or more occlusions.

  In some embodiments, the device can be introduced through the microcatheter (30) by pushing on the central wire (10) and the tube section (27). See Figures 9A and 9D. Spacing wires (191) can maintain the space between receiving elements (68). The capture elements (69) are all fixable to the central wire (10). When exposed (see FIGS. 9B and 9E), the engagement elements may deploy and shorten increasing the distance between the operating units / pairs and also the distance between the individual engagement elements. The distance between the engagement elements as well as between the different operating units / pairs allows the occlusion (blood clot) to penetrate into the space gap. Holding the tube section (27) steady and pulling the center wire proximally (see FIGS. 9C and 9F), the capture element (69) is moved backwards. The space between the capture element and the reception element is all reduced and a portion of the occlusion that has entered the space between the engagement elements is firmly gripped / held or held. The device can then be pulled out of the body cavity (eg, a blood vessel).

  For example, in certain embodiments shown in FIGS. 9A-9C, a relatively large or long length of occlusion can be treated or removed by a device comprising multiple operating units / pairs. In some of such cases, multiple operating units / pairs may cooperatively need to securely grasp and grasp the occlusion. Alternatively or in combination, multiple occlusions can be individually treated or removed by separate operating units / pairs, as shown in FIGS. 9D-9F. As already described elsewhere in the present application, the mechanism for firmly gripping or gripping (engaging, capturing or including) the occlusion by the device may for example be various, (1) occlusion , Which may be captured in the space between the engaging elements, (2) the occlusion may be directly engaged with the wires or struts of the one or more engaging elements, (3) the occlusion may be of the body cavity and the engaging elements Friction may be included between one or more of them, and (4) an occlusion may be included between the body cavity and the space between the engagement elements.

  FIG. 10 shows yet another embodiment of the device where the device may comprise a plurality of engagement elements. In some embodiments, when the device needs to be retracted into the microcatheter (30) during the retrieval procedure, the tube section (27) can be pulled backwards and the receiving element and The space with the capture elements can be increased to prevent them from overlapping one another. Thus, all engagement elements can be pulled into the microcatheter.

  11A and 11B show yet another embodiment of a device in which the device may comprise multiple engagement elements. As an alternative design of the device, in addition to the plurality of operating units / pairs, the device may further comprise an additional element (90) at the distal end of the device. This additional element may function as a distal filter. In certain embodiments, the distal end of the distal filter element is closable by the distal connector (150) to capture clot debris more efficiently. In some embodiments, the outer shape of the distal filter element (90) with respect to size and diameter can be larger than the outer shapes of the other engaging elements and is less rigid than the other engaging elements. This makes it possible to minimize the radial force of the distal filter element on the vessel wall. This most distal engagement element (90) can act to grip / grasp clots or occlusions and act to capture or filter clot debris. Thus, if a clot (or occlusion) breaks up during the recovery procedure and produces multiple pieces, the pieces can be captured (collected or included) within this distal filter element. Since the outer profile of the distal engagement (filter) element is large, preferably larger than the diameter of the blood vessel, strips may not be able to be avoided between the engagement element and the wall of the blood vessel. In FIG. 11, in some embodiments, “**” represents the case where the capture element (69) may be secured to the center wire (10), and “*” indicates that the receiving element (68) is It represents the case where it can be anchored to the pacing wire (191).

  FIG. 12 shows yet another embodiment of the device wherein the device may comprise a plurality of engagement elements. In some embodiments, the device may comprise a central wire (10), a control wire (100), and a plurality of operating units / pairs, for example, each unit / pair comprises two of clot engaging elements With one or more pairs. There may be at least one receiving element and one capturing element in each of the engaging motion units / pairs, and in general, the receiving elements may be disposed proximal to the capturing elements. In some embodiments, some or all of (proximal and intermediate) receiving elements (68) may be fixed to the control wire (100). In some other embodiments, the (distal and central) capture elements (69) are fixable to the central wire (10) via connectors (47, 80). In certain embodiments, the proximal and central receiving elements (68) are associated with (or connected to) the central wire (10) but can slide freely on the central wire.

  In certain embodiments, the control wire (100) may have a handle (120, eg, a type of tube) attached to the proximal end of the control wire, with the central wire inside the handle tube lumen It can slide freely. Additionally, the central wire (10) may be operatively coupled to the handle (110). Thus, by controlling one or both of the control and center wires, the space between the engagement elements can be adjusted to maximize engagement and confinement of the occlusion by the device.

  12A and 12B show the adjustment of the distance between the engagement elements. For example, in the embodiment of FIG. 12B, while holding the control wire handle and pulling the center wire (10) proximally, the capture elements (69) move back to shorten the distance between the reception elements. As the central wire is pulled back (i.e., proximally), the distance between the capture element and the receiving element is reduced, thereby firmly gripping or gripping the clot at various points. As is apparent from the figure, for example, by pushing the control wire distally, the receiving element is moved forward (distally), thereby reducing the distance between the engaging elements. Thus, by controlling the movement of the central wire (10) and / or the control wire (100), the position of both the capture element and the reception element is adjusted, thereby increasing the space between the engagement elements or It can be shortened.

  12C-12E illustrate particular non-limiting examples of connectors, such as (41) and (44), which are configured to engage elements, particularly receiving elements, to move along the center wire but be secured to the control wire. Embodiment is shown. In certain embodiments, the short outer connector tube (43) and the short inner connection tube (45), and the bonding medium (42) are for bonding the control wire (100), the legs of the distal receiving element (40) It can be used for The center wire can slide freely inside the inner connector tube (45). All capture elements are secured to the center wire via connectors (47, 80).

  The control wire and the spacing wire may be from the same wire, which may be tapered downward at the distal segment, to ensure sufficient flexibility of the engagement section It can act as a wire. Thus, in some embodiments, as shown in FIG. 12E, the control wire (100) functions as a spacing wire (190) within the distal portion of the device.

  13A-13F illustrate a further alternative embodiment of a device where the device may comprise multiple operating units / pairs. In some embodiments, all receiving elements (68) are free sliding on the center wire (10) and all capturing elements (69) are center wire via connectors (47, 80) Fixed to form multiple pairs of gripping units / pairs. There may be at least one receiving element and one capturing element in each of the engaging operation units / pairs, and in general, the receiving elements may be disposed proximal to the capturing elements. In some embodiments, relatively thick or stiffer spacing wires (191) may connect them to maintain the space between all the receiving elements (68). Each unit / pair of capture element (69) and reception element (68) is connectable to connection wire (190). All receiving elements can slide freely on the central wire (10). As shown in FIG. 13D, the proximal connector (41) includes spacing wire (191), connecting wire (190), between the outer connecting tube and the inner connecting tube filled with bonding medium (42). And connect the legs (40) of the proximal engagement element. FIG. 13E shows the detailed structure of the receiving engagement element connector (44). The receiving engagement element connector (44) is connected between the connection wire (190) and the receiving engagement element between the outer connection tube (43) and the inner connection tube (45) filled with the bonding medium (42). Connect the legs (40). FIG. 13F shows the spacing wire (191), connection wire (190), and the receiving engagement for engagement between the outer connector tube (43) and the inner connection tube (45) filled with bonding medium (42). Figure 14 shows a similar structure of the connector (44) connecting the legs of the element. The central wire can slide freely inside the inner connector (45). In such embodiments, the capture element (69) may be secured to the center wire via the connectors (47 and 80) and the connection wire (190). All receiving elements are secured to the spacing wire via connectors (41 and 44).

  Furthermore, the connecting wire (191) can be used to maintain the preset space between the paired engagement elements, especially when introducing the device through the microcatheter (30), the same engagement / working unit / pair Connect each pair of capture and reception elements. After exposure and pulling the central wire backwards, the distance between the receiving element and the capturing element can be reduced and the occlusion (blood clot) is gripped, gripped or held between the engaging elements It is possible. The connection wire (190) bends as the device is pulled back into the microcatheter. The elements of each pair may overlap, but the capture element as well as the profile or struts of the distal end of the receiving element can be designed to be small. Thus, when two engagement elements are stacked, these elements are still smaller than the diameter of the microcatheter. Thus, the device is recoverable to the microcatheter. In certain embodiments, the microcatheter can act as a stop for all receiving elements when capturing an occlusion (blood clot) by pulling on the central wire and the capturing element. The advantage of this design is that there is only one handle at the proximal end of the device. The operator only needs to pull on the central wire to reduce the space between the receiving element and the capture element so as to grip the clot. The position of the engagement element is self-aligned and the clot is engaged and held.

  14A-14E illustrate non-limiting constructions of the engagement elements. Alternatively, the engagement is not limited to a cone (FIG. 14A), a sphere (FIG. 14D), an ellipse (FIG. 14D), a parachute (FIG. 14E), a cylinder (FIG. 14C), or any of the above structures It may take the form / shape of a combination (eg, as shown in FIG. 14B). The cylindrical shape may also be closed or open at either the distal or proximal end.

  15A-15B illustrate an alternative non-limiting exemplary embodiment of a structure that may form an engagement element. The engagement element may have a proximal leg (40) and an actual engagement element strut (50). Devices according to some embodiments of the present invention can be manufactured by various techniques known in the art. For example, the engaging elements / struts can be made from thin sheets by a laser cutting process or a photo-etching process. Alternatively, the engagement element can also be made from one piece of hypo-tube material by laser cutting. The struts or laser cut hypo tube shown in FIG. 15 may be heat set to the desired shape and size of the engagement element, and may be further chemically polished or electropolished. The components can be assembled into the retrieval device described in this article.

  While various aspects and embodiments have been disclosed herein, other aspects and embodiments will be apparent to those skilled in the art. The various aspects and embodiments disclosed herein are for illustrative purposes and are not intended to be limiting. The true scope and spirit are indicated by the following claims.

DESCRIPTION OF SYMBOLS 1 body cavity surface 10 center wire 21 inner push tube 23 outer push tube 25 proximal push tube 27 push tube / control tube apartment 30 microcatheter 40 engagement element leg 41 proximal element connector (sliding freely on center wire)
42 bonding medium 43 outer element connector tube 44 center / intermediate element connector (sliding freely on center wire)
45 inner element connector tube 47 capture engagement element connector (locking engagement element on center wire)
Reference Signs List 50 engagement element main body 60 occlusion / clotment 65 proximal engagement element 67 central / intermediate engagement element 68 reception element 69 capture element 80 distal element connector 90 distal engagement element 100 control wire 110 central wire handle 120 Control Wire Handle 150 Distal Element Tip Connector 190 Connecting Wire 191 Spacing Wire

Claims (20)

A device for use in a body cavity,
A central wire having its proximal end and its distal end;
A plurality of engaging elements comprising a distal engaging element, a proximal engaging element, and one or more central engaging elements, each associated with the central wire,
Each of which comprises its distal end and its proximal end,
The distal engagement element is disposed most distally of the plurality of engagement elements and secured to the distal tip of the central wire,
The proximal engagement element is disposed most proximal of the plurality of engagement elements and can slide freely on the center wire,
A plurality of engagements, wherein the one or more central engagement elements are disposed between the distal engagement element and the proximal engagement element and can slide freely on the central wire Elements,
A flexible connection wire connected to the proximal engagement element and at least one other engagement element of the plurality of engagement elements, wherein the connected engagement element is a preset distance A flexible connection wire configured to be placed and installed ;
A proximal end control element disposed proximal to the proximal engagement element, wherein the proximal end of the proximal engagement element is fixed;
Is the distance opened previously set, each adjacent between an open condition, including spaces between connected engagement elements was shortened from the preset distance to the second distance, each adjacent, connected device having a closed state with spaces between been engaging element.   The proximal end control element comprises a tube section comprising its distal end and a proximal end, the proximal end of the proximal engagement element being fixed around the distal end of the tube section The device according to claim 1. The proximal end control element comprises a control wire comprising its distal end and a proximal end, the proximal end of the proximal engagement element being fixed around the distal end of the control wire The device according to claim 1 .   The proximal end control element comprises a wire comprising its distal end and proximal end, the distal segment of the wire being flexible and acting as a connecting wire, all of the engaging elements being the connection The device according to any one of the preceding claims, which is fixed to a wire.   5. The device of any one of the preceding claims, wherein at least one of the plurality of engagement elements comprises a plurality of wires or struts.   6. A device according to any one of the preceding claims, wherein the overall shape of the engagement element is conical, spherical, tubular, ellipsoidal or any combination of said structures. A device according to any of the preceding claims, wherein the flexible connection wire connects with each of the plurality of engagement elements at a preset distance. The device according to any one of the preceding claims, wherein the flexible connection wires connect with each of the plurality of engagement elements at equal distances.   The device according to any of the preceding claims, wherein at least one of the plurality of engagement elements is self-expanding.   10. At least one of the plurality of engagement elements comprises about 3 mm to about 25 mm with respect to a length between the respective proximal end and the respective distal end. Device described in Section.   11. The device according to any of the preceding claims, wherein at least one of the plurality of engagement elements has an open end at its distal end.   12. A device according to any one of the preceding claims, wherein the degree of stiffness of each of the plurality of engagement elements is identical or different from one another.   13. A device according to any one of the preceding claims, wherein the dimensions of each of the plurality of engagement elements are identical or different from one another.   14. A device according to any one of the preceding claims, wherein at least one of the plurality of engagement elements has a closed end at its distal end. The plurality of engagement elements comprise at least two pairs of engagement elements,
15. The device according to any one of the preceding claims, wherein each at least two pairs of engagement elements comprises a capture element and a reception element disposed proximal to the capture element.   16. The device of claim 15, wherein the engagement elements in each at least two pairs of engagement elements operate together as a retrieval unit.   17. A device according to claim 15 or 16, wherein one or more of the receiving elements are secured to a flexible wire using a freely slidable tube connector on the central wire. It said central wire is freely slidable the tube sections, according to any one of claims 2 and 4 to 17 devices. The flexible connecting wire is a flexible or pliable, when the distance between the engaging element is waiting condensation, it is possible to shorten the preset distance between the engaging elements the freely slide 19. A device according to any one of the preceding claims. The closed state, adjacent, connected engagement element, holding the occlusion or clot, a state configured to grip firmly, or gripping, according to any one of claims 1 to 19 device.

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